NA TPT1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885403108488), received between Nov 11, 2022 and Apr 16, 2026 — classified as 1 death, 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2653-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Gas/Air Leak

  IT WAS REPORTED BY CUSTOMER THAT AN ISSUE OCCURRED WHILE USING A TPT1000 THORA PARA 8FR CATHETER DRAINAGE TRAY, IN WHICH THE THREE WAY STOPCOCK HAD AN AIR LEAK THAT PREVENTED THE VACUUM TO WORK APPROPRIATELY. TO COMPLETE THE PROCEDURE, AN ADDITIONAL TRAY WAS OPENED AND A DIFFERENT STOPCOCK WAS USED. NO PATIENT HARM OR STAFF INJURY WAS REPORTED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901405 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLACK SEAL (SELF-SEALING VALVE) LEAKS/SPRAYS WHILE REMOVING THE NEEDLE FROM THE CATHETER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709797 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLACK SEAL (SELF-SEALING VALVE) LEAKS/SPRAYS WHILE REMOVING THE NEEDLE FROM THE CATHETER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709796 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLACK SEAL (SELF-SEALING VALVE) LEAKS/SPRAYS WHILE REMOVING THE NEEDLE FROM THE CATHETER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709793 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLACK SEAL (SELF-SEALING VALVE) LEAKS/SPRAYS WHILE REMOVING THE NEEDLE FROM THE CATHETER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709775 ↗
• MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLACK SEAL (SELF-SEALING VALVE) LEAKS/SPRAYS WHILE REMOVING THE NEEDLE FROM THE CATHETER. NO PATIENT HARM WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE LEAKAGE OCCURRED DURING THE PROCEDURE AND ON EVERY PROCEDURE REPORTED. IT OCCURRED AT THE BLACK SELF-SEAL GOING FROM CATHETER TO SYRINGE/BOTTLE/BAG, WHILE REMOVING THE NEEDLE FROM THE CATHETER THAT IS LEFT IN THE PATIENT TO DRAIN THE FLUID - THE PATIENT FLUID THAT IS DRAINED SPRAYS OUT OF THE SEAL. EVERY TRAY HAD THE BLACK SELF-SEAL THAT LEAKED DURING THIS PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554931 ↗
• MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLACK SEAL (SELF-SEALING VALVE) LEAKS/SPRAYS WHILE REMOVING THE NEEDLE FROM THE CATHETER. NO PATIENT HARM WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE LEAKAGE OCCURRED DURING THE PROCEDURE AND ON EVERY PROCEDURE REPORTED. IT OCCURRED AT THE BLACK SELF-SEAL GOING FROM CATHETER TO SYRINGE/BOTTLE/BAG, WHILE REMOVING THE NEEDLE FROM THE CATHETER THAT IS LEFT IN THE PATIENT TO DRAIN THE FLUID - THE PATIENT FLUID THAT IS DRAINED SPRAYS OUT OF THE SEAL. EVERY TRAY HAD THE BLACK SELF-SEAL THAT LEAKED DURING THIS PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554844 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER A NEEDLE AND CATHETER PLACED WHEN WITHDRAWING NEEDLE FLUID WILL LEAK OUT OF CATHETER. ADDITIONALLY, THE CATHETER KINKS AND THE TUBING WHICH CONNECTS THE CATHETER TO THE BAG CANNOT HANDLE HIGH PRESSURE. UNKNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22378650 ↗
• MalfunctionJun 23, 2025Break; Break

  VERBATIM: WE ARE HAVING ISSUES WITH KIT TPT1000. THREE TIMES THIS WEEK, THE INTRODUCER NEEDLE WITH STOPCOCK HAS BROKEN WHICH IS CAUSING STAFF TO OPEN ANOTHER TRAY. NO MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312177 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UPON OPENING THE GLASS AMPULE OF LIDOCAINE DURING THORACENTESIS AND PARACENTESIS USE, THE TOP OF THE AMPULE CRUSHED CAUSING GLASS SHARDS AND CONTAMINATED THE STERILE TRAY. IT WAS FURTHER REPORTED THAT THE LIDOCAINE VIAL WAS BREAKING INTO SMALL FRAGMENTS AND CAUSED A FINGER LACERATION ON THE USER REQUIRING INTERVENTION, USER WASHED HANDS AND APPLIED A BANDAGE. NO OTHER CARE WAS NEEDED.

  Patient problems: Laceration(s)

  MAUDE report 22048458 ↗
• MalfunctionMay 19, 2025Contamination; Contamination

  IT WAS REPORTED THAT UPON OPENING THE GLASS AMPULE OF LIDOCAINE DURING THORACENTESIS AND PARACENTESIS USE, THE TOP OF THE AMPULE CRUSHED CAUSING GLASS SHARDS AND CONTAMINATED THE STERILE TRAY. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047485 ↗
• MalfunctionMay 19, 2025Contamination; Contamination

  IT WAS REPORTED THAT UPON OPENING THE GLASS AMPULE OF LIDOCAINE DURING THORACENTESIS AND PARACENTESIS USE, THE TOP OF THE AMPULE CRUSHED CAUSING GLASS SHARDS AND CONTAMINATED THE STERILE TRAY. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047470 ↗
• MalfunctionFeb 4, 2025Complete Blockage; Complete Blockage

  MATERIAL # TPT1000. BATCH # 0001598458. IT WAS REPORTED BY CUSTOMER THAT CATHETERS ARE NOT PULLING FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. (B)(4). CATHETERS ARE NOT PULLING FLUID. 4 TOTAL INCIDENTS OVER 5 DAYS NOW FROM (B)(6). REF# (B)(4). LOT¿S 0001597010 AND 0001598458 WERE THE ONES WITH AFFECTED LOTS DURING CASES. ADDITIONAL INFO RECEIVED ON JAN 18, 2025: ADDING SOME CONTEXT TO THE ORIGINAL INCIDENT REPORT: SPOKE WITH DR (B)(6) AND DR(B)(6) AT (B)(6) YESTERDAY IN THE MICU WHERE THE DEVICES WERE USED. HERE IS A DESCRIPTION OF THE EXPERIENCE AND I HAVE COPIED DR(B)(6) INTO THE EMAIL FOR ANY FURTHER FOLLOW UP IF YOU HAVE ADDITIONAL QUESTIONS FOR HER. 5 TOTAL INCIDENTS ACROSS THE LOTS REPORTED BELOW. NO APPARENT INJURIES TO ANY PATIENTS. THE TPT NEEDLE/CATHETER WAS INSERTED INTO THE PATIENT, AND PROVIDER WAS ABLE TO ASPIRATE FLUID THROUGH WITH THE PROVIDED SYRINGE IN (B)(4) INCIDENTS, BUT THERE WAS AN INCIDENT WHERE THE INITIAL PULL OF THE SYRINGE DIDN¿T ASPIRATE ANY FLUID. THE COMMON EXPERIENCE OF DEVICE FAILURE APPEARS TO BE AFTER THE NEEDLE WAS TAKEN OUT WITH THE CATHETER LEFT IN THE PATIENT. AS WE KNOW, THE TPT NEEDLE HAS A SAFETY FEATURE WHEREBY THE NEEDLE CANNOT B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309553 ↗
• MalfunctionFeb 4, 2025Complete Blockage; Complete Blockage

  MATERIAL # TPT1000. BATCH # 0001597010. IT WAS REPORTED BY CUSTOMER THAT CATHETERS ARE NOT PULLING FLUID. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CATHETERS ARE NOT PULLING FLUID. 4(B)(4) TOTAL INCIDENTS OVER 5 DAYS NOW FROM (B)(6) REF# (B)(4). LOT¿S 0001597010. AND (B)(4) WERE THE ONES WITH AFFECTED LOTS DURING CASES. ADDITIONAL INFO RECEIVED ON JAN 18, 2025: SPOKE WITH DR (B)(6) AND DR(B)(6) AT (B)(6) YESTERDAY IN THE MICU WHERE THE DEVICES WERE USED. HERE IS A DESCRIPTION OF THE EXPERIENCE AND I HAVE COPIED DR (B)(6) INTO THE EMAIL FOR ANY FURTHER FOLLOW UP IF YOU HAVE ADDITIONAL QUESTIONS FOR HER. (B)(4) TOTAL INCIDENTS ACROSS THE LOTS REPORTED BELOW. NO APPARENT INJURIES TO ANY PATIENTS. THE TPT NEEDLE/CATHETER WAS INSERTED INTO THE PATIENT, AND PROVIDER WAS ABLE TO ASPIRATE FLUID THROUGH WITH THE PROVIDED SYRINGE IN (B)(4) INCIDENTS, BUT THERE WAS AN INCIDENT WHERE THE INITIAL PULL OF THE SYRINGE DIDN¿T ASPIRATE ANY FLUID. THE COMMON EXPERIENCE OF DEVICE FAILURE APPEARS TO BE AFTER THE NEEDLE WAS TAKEN OUT WITH THE CATHETER LEFT IN THE PATIENT. AS WE KNOW, THE TPT NEEDLE HAS A SAFETY FEATURE WHEREBY THE NEEDLE CANNOT BE REINSERTED AFTER IT HAS BEEN TAKEN OUT. SO, THE CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309550 ↗
• MalfunctionJan 16, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY CONSUMER THAT LICAINE DID NOT NUMB THE PATIENT. VERBATIM: DESCRIPTION: LICAINE DID NOT NUMB THE PATIENT. RESPONSE RECEIVED. WAS THE LIDOCAINE NOT EFFECTIVE? IT WAS NOT EFFECTIVE. WHAT WAS THE IMPACT TO THE PATIENT? THE PATIENT COULD FEEL STILL DURING THE PROCEDURE, A DIFFERENT LIDOCAINE WAS USED. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS. NO. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? USED A DIFFERENT LIDOCAINE AFTER THE PATIENTS REMARKS. HOW WAS THE ISSUE RESOLVED? USED A DIFFERENT LIDOCAINE AFTER THE PATIENTS REMARKS. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO, THE ONLY THING I HAVE ARE THE OUTER PACKAGE OF THE TRAY ITSELF. CAN YOU PROVIDE A EXACT DATE OF EVENT? 12/27. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? YES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519526 ↗
• MalfunctionJan 16, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY CONSUMER THAT LICAINE DID NOT NUMB THE PATIENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DESCRIPTION: LICAINE DID NOT NUMB THE PATIENT LOT: 001526865. LIDOCAINE LOT: GT7587. LOT: 001520449. LIDOCAINE LOT: GT7587. CATALOG NUMBER: TPT1000. PLEASE REACH OUT AND REQUEST TO VERIFY THE FOLLOWING: ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO, THE ONLY THING I HAVE ARE THE OUTER PACKAGE OF THE TRAY ITSELF. CAN YOU PROVIDE A EXACT DATE OF EVENT? 12/27. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? YES. RESPONSE RECEIVED: WAS THE LIDOCAINE NOT EFFECTIVE? IT WAS NOT EFFECTIVE. WHAT WAS THE IMPACT TO THE PATIENT? THE PATIENT COULD FEEL STILL DURING THE PROCEDURE, A DIFFERENT LIDOCAINE WAS USED. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS: NO. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? USED A DIFFERENT LIDOCAINE AFTER THE PATIENTS REMARKS. HOW WAS THE ISSUE RESOLVED? USED A DIFFERENT LIDOCAINE AFTER THE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518166 ↗
• MalfunctionSep 14, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING EVERY PROCEDURE, THE CATHETER USED COLLAPSES. VERBATIM: THE CUSTOMER REPORTS THAT DURING EVERY PROCEDURE, THE CATHETER USED COLLAPSES. NEEDING TO KNOW IF COMPONENTS OF THE TRAY HAVE CHANGED. REQUESTING REPLACEMENT. DISTRIBUTOR: MEDLINE. PRIMARY CONTACT WILL BE OUT OF TOWN IN 2 WEEKS FROM COMPLAINT SUBMISSION. REQUESTS FOR ALTERNATE CONTACT DINA TO BE CONTACTED AS WELL. REF# (B)(4). LOT# NOT AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17745001 ↗
• MalfunctionJan 3, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT THEY ENCOUNTERED THE NEEDLES USED TO INJECT LIDOCAINE, BEING BLOCKED AS WELL AS THE T CONNECTOR TUBING LUMEN BEING BLOCKED. VERBATIM: PI-IS VERBATIM: MAT# TPT1000 I¿M HOPING YOU CAN ASSIST. WE HAVE A PRODUCT COMPLAINT WITH TPT1000 WHICH I UNDERSTAND FROM OUR VYAIRE RESPIRATORY REP IS OWNED BY BD. I NEED SOME ASSISTANCE IN NAVIGATING REPORTING THE ISSUE NOTED BELOW FOR DOCUMENTATION PURPOSES. LAST WEEK WHILE ATTEMPTING TO PERFORM A THORACENTESIS ON THE STEP-DOWN UNIT, I ENCOUNTERED NUMEROUS PROBLEMS WITH THE EQUIPMENT DASH TRAY. THE NEEDLES WHICH WE WOULD USE TO INJECT LIDOCAINE WHERE PHYSICALLY BLOCKED, AND I WAS UNABLE TO INJECT ANYTHING THROUGH THEM. THE T CONNECTOR TUBING LUMEN WAS ALSO BLOCKED, AND I WAS UNABLE TO INJECT OR ASPIRATE THROUGH IT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS RL. TO COMPLETE THE PROCEDURE, MULTIPLE THORACENTESIS KITS WERE OPENED TO PIECE TOGETHER A COMPLETE KIT. I DO NOT HAVE THE LOT NUMBER OR THE FAULTY SUPPLIES, AS THEY WERE NOT SAVED. THERE WERE NOT MISSING PIECES, THE KITS WERE OPENED DUE TO THE BLOCKAGES. I DO NOT HAVE ANY PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090886 ↗
• DeathNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE PHYSICIAN WAS MET WITH RESISTANCE WHEN INSERTING THE CATHETER. DESCRIBE THE EVENT OR PROBLEM: THE PHYSICIAN HAD NOT USED THIS KIT BEFORE (HE WAS USED TO A SELDINGER TECHNIQUE, AND THIS ONE HAS A TROCAR). DOCTOR MET RESISTANCE (PERCEIVED AS NORMAL RESISTANCE WHEN INSERTING A CHEST TUBE). DR. CONTINUED INSERTING THE CATHETER, AND NOTED PULSATING BLOOD COMING OUT OF THE PIGTAIL. THE TROCAR IS VERY RIGID AND THIS MAY HAVE CONTRIBUTED TO THE CARDIAC PUNCTURE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CHEST TUBE FOR PNEUMOTHORAX WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) : DEVICE WAS HARD TO USE; PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: COPD; ADVERSE EVENT DEATH ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 ¿ WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? PIGTAIL CHEST TUBE INSERTION FOR PNEUMOTHORAX ¿ WHAT WAS DONE TO RESOLVE THE ISSUE? ONCE A SIGNIFICANT ISSUE WAS IDENTIFIED, A TRADITIONAL CHEST TUBE WAS PLACED ¿ WHAT WAS THE IMPACT TO THE PATIENT? DEATH VIA PUNCTURE TO THE PATIENT¿S HEART ¿ ARE THERE ANY PHOTOS TO SHOW THE REPORTED ISSUE? NO ¿ PLEASE PROVIDE THE LOT NUMBER FOR THE PRODUCT. 14588661 ¿ WHAT

  Patient problems: Cardiac Perforation

  MAUDE report 15783724 ↗